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Outcomes Following Pre-marking of Episiotomy Location

NCT ID: NCT04719533

Last Updated: 2021-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-17

Study Completion Date

2025-09-24

Brief Summary

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To compare short- and long-term outcomes of women following episiotomy during the second stage of labor, following marking of episiotomy location during the first stage of labor with those of women who underwent episiotomy without marking.

Detailed Description

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Purpose: To compare short- and long-term outcomes of women following episiotomy during the second stage of labor, following marking of episiotomy location during the first stage of labor with those of women who underwent episiotomy without marking.

Hypothesis: Women following episiotomy following pre-marking of the location will suffer from fewer short- and long-term complications compared to those without pre-marked episiotomy location.

Study type: prospective randomized-controlled trial

Conditions

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Episiotomy; Complications Episiotomy Extended by Laceration Episiotomy Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective randomized-controlled trial
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
Patients' data recorded according to a coding system

Study Groups

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Pre-marked episiotomy location

Women in this group will undergo pre-marking of episiotomy location

Group Type EXPERIMENTAL

Pre-marking of episiotomy location

Intervention Type OTHER

A template marking the pre-determined correct location of episiotomy will be used to mark to women in the interventional group

No pre-marked episiotomy location

Women in this group will not undergo pre-marking of episiotomy location

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pre-marking of episiotomy location

A template marking the pre-determined correct location of episiotomy will be used to mark to women in the interventional group

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* women 18 years of age or older who present in active labour to our center and consent to participate in the study

Exclusion Criteria

* women under 18 years of age or those who do not or are unable to provide informed consent to participate in the study
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sharon Davidesko MD

OTHER

Sponsor Role lead

Responsible Party

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Sharon Davidesko MD

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sharon Davidesko, MD

Role: PRINCIPAL_INVESTIGATOR

Soroka University Medical Center

Locations

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Soroka University Medical Center

Beersheba, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Sharon Davidesko, MD

Role: CONTACT

[email protected]
+972546837362

Facility Contacts

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Sharon Davidesko, MD

Role: primary

[email protected]
+972546837362

Other Identifiers

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SOR-0089-20-CTIL

Identifier Type: -

Identifier Source: org_study_id